MTX Discontinuation and Vaccine Response

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

Summary

To investigate whether a short term discontinuation of methotrexate (MTX) will improve the vaccination efficacy to seasonal influenza vaccination without deteriorating RA disease activity in a randomized clinical trial.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Methotrexate; Vaccines

Criteria

Inclusion Criteria:

• Males or females > 18 years at time of consent

• Have a diagnosis of RA per ACR criteria

• Must understand and voluntarily sign an informed consent form including writing consent for data protection

• Stable doses of methotrexate over the preceding 6 weeks

Exclusion Criteria:

• Pregnant or lactating females

• Previous anaphylactic response to vaccine components or to egg.

• Acute infection with T >38°C at the time of vaccination

• History of Guillain-Barre syndrome or demyelinating syndromes

• Previous vaccination with any live vaccine 4 weeks before or any inactivated vaccine 2 weeks before the study

• Blood transfusion within 6 months

• Active rheumatoid arthritis necessitating a recent change in the drug regimen

• Any other rheumatic disease such as systemic lupus erythematosus, mixed connective tissue disease, dermatomyositis/polymyositis, and vasculitis except for secondary Sjogren's disease